Schwert
Scaler and band seater, serrated 16,5cm
12manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 19 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Jiangsu Province Yangzhou Shuguang Toothbrush Manufactory | Yang Zhou | Jiangsu | Manufacturer | 15 |
| Ningbo Denrotary Medical Apparatus Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 9 |
| Pesitro Healthcare Products Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 7 |
Record
| Listed by | A. Schweickhardt Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | ECS |
| Device type | Pusher, Band, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-03-06 |
| Record revised | 2024-03-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4960-349 | In distribution | |
| 4960-358 | In distribution | |
| 4960-49 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Power Dental USA | Power Dental U.S.A. Inc. | 26 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 25 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 15 |
| Chewies ™ | Dentsply Sirona Orthodontics Inc. | 12 |
| JMU | JMU Dental, Inc | 9 |
| Ortho Technology® | Ortho Organizers, Inc. | 9 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 8 |
| Precision Dental Instruments | Precision Dental Instruments | 7 |
| Leone SPA | Leone SPA | 7 |
| Zoll Dental | Zoll-Dental | 6 |
| Color Coded Bite Sticks | Ortho Technology, Inc. | 6 |
| Young Specialties | Young Innovations Inc. | 5 |
Showing 12 of 47. All products under Pusher, Band, Orthodontic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.